Novo Nordisk A/S : showcases next-gen GLP-1 at EASD
Currently under review by regulators in the US,
Novo is presenting new analysis of five clinical trials at EASD showing the drug reduced blood sugar and helped them lose weight better than comparator treatments.
Comparators included placebo, Merck & Cos Januvia (sitagliptin), Sanofis Lantus (insulin glargine) and crucially AstraZenecas weekly GLP-1 rival, Bydureon (exenatide).
Semaglutide is predicted to be a blockbuster for
Early data suggests it could provide better blood glucose control than Victoza, which generated sales of
Peak sales of semaglutide are predicted to exceed
Novo is also developing an oral version of semaglutide, which could put even more pressure on rivals in the diabetes drug market.
Novos analysis of the SUSTAIN 1-5 phase 3 trials showed significantly more people treated with once-weekly semaglutide achieved a composite endpoint of at least 1% HbA1C reduction and greater than 5% weight loss compared with all comparators.
The effect was significant at 0.5mg dose and 1mg dose across all comparators in SUSTAIN 1-5.
More people achieved the composite endpoint with once-weekly semaglutide 1.0 mg compared with semaglutide 0.5 mg in SUSTAIN 2,4 and 5, although the difference was not statistically significant in SUSTAIN 1.
Semaglutide was well tolerated, with a safety profile similar to that of other GLP-1 (glucagon-like peptide-1 receptor) agonists.
The most common adverse event with semaglutide was nausea. In SUSTAIN 1-4, severe or blood glucose confirmed symptomatic hypoglycaemia events were fewer or similar with once-weekly semaglutide versus comparators. In SUSTAIN 5, on a background of basal insulin, more events were observed with once-weekly semaglutide than with placebo.
Novo is also showcasing results from its Fiasp (fast-acting insulin aspart) in type 1 diabetes. The ultra-fast acting mealtime insulin improved HbA1c and post-meal sugar control over 52 weeks compared with its older fast-acting insulin, NovoRapid.
Results from the phase 3 onset 1 trial confirmed findings seen over a shorter-term 26-week study period, and reconfirmed Fiasps safety profile, showing comparable overall numbers of severe or blood-sugar confirmed hypoglycaemia.
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